Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 ballot
Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions
| Page standards status: Informative |
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<id value="419455"/>
<meta>
<versionId value="6"/>
<lastUpdated value="2026-01-05T17:01:47.553Z"/>
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<language value="en"/>
<text>
<status value="generated"/>
<div xmlns="http://www.w3.org/1999/xhtml"><p class="res-header-id"><b>Generated Narrative: CodeSystem 419455</b></p><a name="419455"> </a><a name="hc419455"> </a><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">version: 6; Last updated: 2026-01-05 17:01:47+0000</p></div><p>This code system <code>https://fevir.net/resources/CodeSystem/419455</code> defines the following codes:</p><table class="codes"><tr><td style="white-space:nowrap"><b>Code</b></td><td><b>Display</b></td><td><b>Definition</b></td></tr><tr><td style="white-space:nowrap">fda-regulated-drug<a name="419455-fda-regulated-drug"> </a></td><td>FDA regulated drug</td><td>A medication regulated by the U.S. Food and Drug Administration.</td></tr><tr><td style="white-space:nowrap">fda-regulated-device<a name="419455-fda-regulated-device"> </a></td><td>FDA regulated device</td><td>A medical device regulated by the U.S. Food and Drug Administration.</td></tr><tr><td style="white-space:nowrap">irb-exempt<a name="419455-irb-exempt"> </a></td><td>IRB-exempt</td><td>Human subjects research that is excempt from oversight and monitoring by an institutional review board (IRB).</td></tr><tr><td style="white-space:nowrap">mpg-paragraph-23b<a name="419455-mpg-paragraph-23b"> </a></td><td>MPG Paragraph 23b</td><td>Research regulated by a specific German legal requirement (Medizinproduktegesetz MPG Paragraph 23b).</td></tr><tr><td style="white-space:nowrap">includes-females<a name="419455-includes-females"> </a></td><td>Includes female subjects</td><td>Includes female subjects</td></tr><tr><td style="white-space:nowrap">does-not-include-females<a name="419455-does-not-include-females"> </a></td><td>Does not include female subjects</td><td>Does not include female subjects</td></tr><tr><td style="white-space:nowrap">includes-males<a name="419455-includes-males"> </a></td><td>Includes male subjects</td><td>Includes male subjects</td></tr><tr><td style="white-space:nowrap">does-not-include-males<a name="419455-does-not-include-males"> </a></td><td>Does not include male subjects</td><td>Does not include male subjects</td></tr><tr><td style="white-space:nowrap">includes-vulnerable-population<a name="419455-includes-vulnerable-population"> </a></td><td>Includes vulnerable populations</td><td>Includes vulnerable populations</td></tr><tr><td style="white-space:nowrap">does-not-include-vulnerable-population<a name="419455-does-not-include-vulnerable-population"> </a></td><td>Does not include vulnerable populations</td><td>Does not include vulnerable populations</td></tr><tr><td style="white-space:nowrap">includes-healthy-volunteers<a name="419455-includes-healthy-volunteers"> </a></td><td>Includes healthy volunteers</td><td>Includes healthy volunteers</td></tr><tr><td style="white-space:nowrap">does-not-include-healthy-volunteers<a name="419455-does-not-include-healthy-volunteers"> </a></td><td>Does not include healthy volunteers</td><td>Does not include healthy volunteers</td></tr><tr><td style="white-space:nowrap">includes-ages-in-utero<a name="419455-includes-ages-in-utero"> </a></td><td>Includes ages in utero</td><td>Includes subjects who are not yet born</td></tr><tr><td style="white-space:nowrap">includes-ages-0-17<a name="419455-includes-ages-0-17"> </a></td><td>Includes ages 0-17 years</td><td>Includes subjects between birth and 17 years of age (not yet 18 years old)</td></tr><tr><td style="white-space:nowrap">includes-ages-18-64<a name="419455-includes-ages-18-64"> </a></td><td>Includes ages 18-64 years</td><td>Includes subjects between 18 and 64 years of age (not yet 65 years old)</td></tr><tr><td style="white-space:nowrap">includes-ages-65-and-older<a name="419455-includes-ages-65-and-older"> </a></td><td>Includes ages 65 and older</td><td>Includes subjects aged 65 years and older</td></tr><tr><td style="white-space:nowrap">includes-preterm-newborns<a name="419455-includes-preterm-newborns"> </a></td><td>Includes preterm newborns</td><td>Includes subjects who are preterm newborns (up to gestational age < 37 weeks)</td></tr><tr><td style="white-space:nowrap">includes-neonates<a name="419455-includes-neonates"> </a></td><td>Includes neonates</td><td>Includes subjects between 0 and 27 days of age</td></tr><tr><td style="white-space:nowrap">includes-ages-28-day-23-month<a name="419455-includes-ages-28-day-23-month"> </a></td><td>Includes ages 28 days to 23 months</td><td>Includes subjects between 28 days and 23 months of age</td></tr><tr><td style="white-space:nowrap">includes-ages-2-5<a name="419455-includes-ages-2-5"> </a></td><td>Includes ages 2-5 years</td><td>Includes subjects between 2 and 5 years of age (not yet 6 years old)</td></tr><tr><td style="white-space:nowrap">includes-ages-6-11<a name="419455-includes-ages-6-11"> </a></td><td>Includes ages 6-11 years</td><td>Includes subjects between 6 and 11 years of age (not yet 12 years old)</td></tr><tr><td style="white-space:nowrap">includes-ages-12-17<a name="419455-includes-ages-12-17"> </a></td><td>Includes ages 12-17 years</td><td>Includes subjects between 12 and 17 years of age (not yet 18 years old)</td></tr><tr><td style="white-space:nowrap">includes-ages-65-84<a name="419455-includes-ages-65-84"> </a></td><td>Includes ages 65-84 years</td><td>Includes subjects between 65 and 84 years of age (not yet 85 years old)</td></tr><tr><td style="white-space:nowrap">includes-ages-85-and-older<a name="419455-includes-ages-85-and-older"> </a></td><td>Includes ages 85 and older</td><td>Includes subjects aged 85 years and older</td></tr></table></div>
</text>
<extension url="http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as">
<valueMarkdown
value="ResearchStudy Classifier Code System [Database Entry: FHIR CodeSystem Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 419455. Revised 2026-01-05. Available at: https://fevir.net/resources/CodeSystem/419455. Computable resource at: https://fevir.net/resources/CodeSystem/419455#json."/>
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<url value="https://fevir.net/resources/CodeSystem/419455"/>
<identifier>
<type>
<coding>
<system value="http://terminology.hl7.org/CodeSystem/v2-0203"/>
<code value="ACSN"/>
<display value="Accession ID"/>
</coding>
<text value="FEvIR Object Identifier"/>
</type>
<system value="https://fevir.net/FOI"/>
<value value="419455"/>
<assigner>
<display value="Computable Publishing LLC"/>
</assigner>
</identifier>
<identifier>
<system value="urn:ietf:rfc:3986"/>
<value value="urn:oid:2.16.840.1.113883.4.642.40.44.16.8"/>
</identifier>
<version value="1.0.0-ballot3"/>
<name value="ResearchStudyClassifierCodeSystem"/>
<title value="ResearchStudy Classifier Code System"/>
<status value="active"/>
<date value="2026-01-08T11:24:31+00:00"/>
<publisher value="HL7 International / Clinical Decision Support"/>
<contact>
<name value="HL7 International / Clinical Decision Support"/>
<telecom>
<system value="url"/>
<value value="http://www.hl7.org/Special/committees/dss"/>
</telecom>
</contact>
<description
value="This CodeSystem is used for common values for the ResearchStudy.classifier element and will likely move to terminology.hl7.org when it is mature."/>
<jurisdiction>
<coding>
<system value="http://unstats.un.org/unsd/methods/m49/m49.htm"/>
<code value="001"/>
<display value="World"/>
</coding>
</jurisdiction>
<copyright value="https://creativecommons.org/licenses/by-nc-sa/4.0/"/>
<author>
<name value="Brian S. Alper, MD, MSPH"/>
</author>
<valueSet value="https://fevir.net/resources/ValueSet/419456"/>
<content value="complete"/>
<concept>
<code value="fda-regulated-drug"/>
<display value="FDA regulated drug"/>
<definition
value="A medication regulated by the U.S. Food and Drug Administration."/>
</concept>
<concept>
<code value="fda-regulated-device"/>
<display value="FDA regulated device"/>
<definition
value="A medical device regulated by the U.S. Food and Drug Administration."/>
</concept>
<concept>
<code value="irb-exempt"/>
<display value="IRB-exempt"/>
<definition
value="Human subjects research that is excempt from oversight and monitoring by an institutional review board (IRB)."/>
</concept>
<concept>
<code value="mpg-paragraph-23b"/>
<display value="MPG Paragraph 23b"/>
<definition
value="Research regulated by a specific German legal requirement (Medizinproduktegesetz MPG Paragraph 23b)."/>
</concept>
<concept>
<code value="includes-females"/>
<display value="Includes female subjects"/>
<definition value="Includes female subjects"/>
</concept>
<concept>
<code value="does-not-include-females"/>
<display value="Does not include female subjects"/>
<definition value="Does not include female subjects"/>
</concept>
<concept>
<code value="includes-males"/>
<display value="Includes male subjects"/>
<definition value="Includes male subjects"/>
</concept>
<concept>
<code value="does-not-include-males"/>
<display value="Does not include male subjects"/>
<definition value="Does not include male subjects"/>
</concept>
<concept>
<code value="includes-vulnerable-population"/>
<display value="Includes vulnerable populations"/>
<definition value="Includes vulnerable populations"/>
</concept>
<concept>
<code value="does-not-include-vulnerable-population"/>
<display value="Does not include vulnerable populations"/>
<definition value="Does not include vulnerable populations"/>
</concept>
<concept>
<code value="includes-healthy-volunteers"/>
<display value="Includes healthy volunteers"/>
<definition value="Includes healthy volunteers"/>
</concept>
<concept>
<code value="does-not-include-healthy-volunteers"/>
<display value="Does not include healthy volunteers"/>
<definition value="Does not include healthy volunteers"/>
</concept>
<concept>
<code value="includes-ages-in-utero"/>
<display value="Includes ages in utero"/>
<definition value="Includes subjects who are not yet born"/>
</concept>
<concept>
<code value="includes-ages-0-17"/>
<display value="Includes ages 0-17 years"/>
<definition
value="Includes subjects between birth and 17 years of age (not yet 18 years old)"/>
</concept>
<concept>
<code value="includes-ages-18-64"/>
<display value="Includes ages 18-64 years"/>
<definition
value="Includes subjects between 18 and 64 years of age (not yet 65 years old)"/>
</concept>
<concept>
<code value="includes-ages-65-and-older"/>
<display value="Includes ages 65 and older"/>
<definition value="Includes subjects aged 65 years and older"/>
</concept>
<concept>
<code value="includes-preterm-newborns"/>
<display value="Includes preterm newborns"/>
<definition
value="Includes subjects who are preterm newborns (up to gestational age < 37 weeks)"/>
</concept>
<concept>
<code value="includes-neonates"/>
<display value="Includes neonates"/>
<definition value="Includes subjects between 0 and 27 days of age"/>
</concept>
<concept>
<code value="includes-ages-28-day-23-month"/>
<display value="Includes ages 28 days to 23 months"/>
<definition
value="Includes subjects between 28 days and 23 months of age"/>
</concept>
<concept>
<code value="includes-ages-2-5"/>
<display value="Includes ages 2-5 years"/>
<definition
value="Includes subjects between 2 and 5 years of age (not yet 6 years old)"/>
</concept>
<concept>
<code value="includes-ages-6-11"/>
<display value="Includes ages 6-11 years"/>
<definition
value="Includes subjects between 6 and 11 years of age (not yet 12 years old)"/>
</concept>
<concept>
<code value="includes-ages-12-17"/>
<display value="Includes ages 12-17 years"/>
<definition
value="Includes subjects between 12 and 17 years of age (not yet 18 years old)"/>
</concept>
<concept>
<code value="includes-ages-65-84"/>
<display value="Includes ages 65-84 years"/>
<definition
value="Includes subjects between 65 and 84 years of age (not yet 85 years old)"/>
</concept>
<concept>
<code value="includes-ages-85-and-older"/>
<display value="Includes ages 85 and older"/>
<definition value="Includes subjects aged 85 years and older"/>
</concept>
</CodeSystem>
IG © 2024+ HL7 International / Clinical Decision Support.
Package hl7.fhir.uv.ebm#1.0.0-ballot3 based on FHIR 6.0.0-ballot3.
Generated
2026-01-08
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